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Impact of Intravitreal Aflibercept Injections on Capillary Non-Perfusion (ANDROID)

Primary Purpose

Central Retinal Vein Occlusion, Proliferative Diabetic Retinopathy

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Intravitreal Aflibercept Injection

About this trial

This is an interventional treatment trial for Central Retinal Vein Occlusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of one or more of the following:
Proliferative retinopathy (PDR) Macular edema secondary to CRVO Proliferative disease secondary to CRVO (anterior segment or posterior segment neovascularization).
Be in need of IAI treatment, whether previously treated or treatment-naïve.
Age > 18 years.

Exclusion Criteria:

Subjects with macular edema secondary to diabetic retinopathy without concomitant proliferative diabetic retinopathy.
Subjects with cataract or other media opacities impairing adequate visualization of the retina to the extent that good quality images are impossible.
Presence of any substantial ocular disease (other than diabetic retinopathy or central retinal vein occlusion) that may compromise vision in the study eye and /or confound interpretation of the data; e.g. substantial cataracts, advanced glaucoma, optic neuritis, optic neuropathy or atrophy, marked macular atrophy, history of retinal detachment, uveitis, viral or other forms of chorioretinitis, etc.
Active intraocular inflammation (grade trace or above) in the study eye, or history of idiopathic or autoimmune-associated uveitis in either eye.
Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma medication).
History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye.
Participation in a study of an investigational drug or device within 30 days prior to potential enrollment into the study.
Intraocular surgery (including cataract surgery) in the study eye within 60 days preceding baseline.
History of vitrectomy surgery in the study eye.
Subjects with 12 or more anti-VEGF injections within 24 months prior to Screening.
Subjects who received anti-VEGF therapy within 30 days of Screening or received steroid or laser therapy within 90 days of Screening.
Subjects allergic to fluorescein, povidone iodine (Betadyne) or aflibercept
Pregnant or breast-feeding women.

Sites / Locations

Ophthalmic Consultants of Boston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Every Month Treatment

Every Month, then Every Other Month

Arm Description

Patients will receive Intravitreal Aflibercept Injection (IAI) every month for the 12 month duration of the study.

Patients will receive Intravitreal Aflibercept Injection (IAI) every month for the first 6 months, then every other month for the next 6 months. Retreatment criteria will allow for patients to be treated every month in the second 6 months if needed.

Outcomes

Primary Outcome Measures

Mean Change in Capillary Non-Perfusion

To determine mean change in the presence and amount of capillary non-perfusion as measured by wide-angle angiography using Optos 200Tx system at Baseline, Month 3, Month 6, and Month 12.

Secondary Outcome Measures

Full Information

NCT ID

NCT01724554

First Posted

November 7, 2012

Last Updated

May 21, 2015

Sponsor

Ophthalmic Consultants of Boston

Collaborators

Regeneron Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01724554

Brief Title

Impact of Intravitreal Aflibercept Injections on Capillary Non-Perfusion

Acronym

ANDROID

Official Title

A Single-center, Open-label Study Evaluating the Impact of Repeat Intravitreal Injections of Aflibercept on Capillary Non-Perfusion (CNP) in Subjects With Proliferative Retinopathy and/or Macular Edema Secondary to Proliferative Diabetic Retinopathy and Central Retinal Venous Occlusive Disease

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

November 2012 (undefined)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ophthalmic Consultants of Boston

Collaborators

Regeneron Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to look at how effective, safe, and well tolerated Intravitreal Aflibercept Injection is in subjects with Central Retinal Vein Occlusion (CRVO) or Proliferative Diabetic Retinopathy (PDR).

Detailed Description

Protocol available upon request.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Central Retinal Vein Occlusion, Proliferative Diabetic Retinopathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Every Month Treatment

Arm Type

Experimental

Arm Description

Patients will receive Intravitreal Aflibercept Injection (IAI) every month for the 12 month duration of the study.

Arm Title

Every Month, then Every Other Month

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Intravitreal Aflibercept Injection

Other Intervention Name(s)

IAI

Intervention Description

Aflibercept administered to the eye intravitreally either every month or every other month.

Primary Outcome Measure Information:

Title

Mean Change in Capillary Non-Perfusion

Description

To determine mean change in the presence and amount of capillary non-perfusion as measured by wide-angle angiography using Optos 200Tx system at Baseline, Month 3, Month 6, and Month 12.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of one or more of the following: Proliferative retinopathy (PDR) Macular edema secondary to CRVO Proliferative disease secondary to CRVO (anterior segment or posterior segment neovascularization). Be in need of IAI treatment, whether previously treated or treatment-naïve. Age > 18 years. Exclusion Criteria: Subjects with macular edema secondary to diabetic retinopathy without concomitant proliferative diabetic retinopathy. Subjects with cataract or other media opacities impairing adequate visualization of the retina to the extent that good quality images are impossible. Presence of any substantial ocular disease (other than diabetic retinopathy or central retinal vein occlusion) that may compromise vision in the study eye and /or confound interpretation of the data; e.g. substantial cataracts, advanced glaucoma, optic neuritis, optic neuropathy or atrophy, marked macular atrophy, history of retinal detachment, uveitis, viral or other forms of chorioretinitis, etc. Active intraocular inflammation (grade trace or above) in the study eye, or history of idiopathic or autoimmune-associated uveitis in either eye. Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma medication). History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye. Participation in a study of an investigational drug or device within 30 days prior to potential enrollment into the study. Intraocular surgery (including cataract surgery) in the study eye within 60 days preceding baseline. History of vitrectomy surgery in the study eye. Subjects with 12 or more anti-VEGF injections within 24 months prior to Screening. Subjects who received anti-VEGF therapy within 30 days of Screening or received steroid or laser therapy within 90 days of Screening. Subjects allergic to fluorescein, povidone iodine (Betadyne) or aflibercept Pregnant or breast-feeding women.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeffrey S Heier, MD

Organizational Affiliation

Ophthalmic Consultants of Boston

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ophthalmic Consultants of Boston

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

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Impact of Intravitreal Aflibercept Injections on Capillary Non-Perfusion

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